GlaucomaPhase 4NCT04647461
Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
A Phase 4 study testing Brimonidine Tartrate 1.5mg in people with Glaucoma and Ocular Hypertensive, run by CHA University at 1 site in South Korea.
Trial summary
Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertensive
- What is being tested?
- Brimonidine Tartrate 1.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2019to 29 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension
- In the case of a person receiving a glaucoma treatment drug, a person who has completed the appropriate in wash-out period for the existing glaucoma drug before the investigational product is administered.
- Intraocular pressure (IOP) >/= 15mmHg and < 40mmHg in each eye using Goldmann applanation tonometry at visit 2
- Written consent voluntarily to participate in this clinical trial
Who cannot join
- Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
- BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
- Those who have ongoing medical history as intraocular inflamation.
- Central corneal thickness is not between 470um and 591um.
- Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.
- Pregnant or nursing women.
- Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA University Bundang Medical Center
Seongnam, Bundang-gu, 13497
About this study
Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
Read the detailed description
Following 12 weeks of administration of BRIDIN-T Eye drops 0.15%(non preservative) or ALPHAGAN-P Eye drops 0.15%(preservatives) for patients with glaucoma or Ocular Hypertensive Patients. The use of BRIDIN-T Eye drops(non preservative) is less harmful to external ophthalmicus diseases and increase of medication compliance for ophthalmic drugs than the ALPHAGAN-P Eye drops 0.15%(preservatives)
- Conditions
- Glaucoma, Ocular Hypertensive
- Being tested
- Brimonidine Tartrate 1.5mg
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine Tartrate 1.5mgDrug
Also called BRIDIN-T Eye drops 0.15%
1 drop 3 times a day for 12 weeks to target eyes
Brimonidine Tartrate 1.5mgDrug
Also called ALPHAGAN-P Eye drops 0.15%
1 drop 3 times a day for 12 weeks to target eyes
| Study group | Role | What they receive |
|---|---|---|
| BRIDIN-T Eye drops 0.15%(Non preservative) | Experimental | Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes Receives: Drug: Brimonidine Tartrate 1.5mg |
| ALPHAGAN-P Eye drops 0.15%(Preservatives) | Active comparator | Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes Receives: Drug: Brimonidine Tartrate 1.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal staining test
The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system
Measured: Administered 12 weeks after
Conjunctival staining test
After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system
Measured: Administered 12 weeks after
Ocular surface disease index (OSDI)
The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.
Measured: Administered 12 weeks after
Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
The evaluation of satisfaction with medication is conducted with a questionnaire evaluation on the convenience of use, storage of investigational product, and the ocular tolerance.
Evaluation is conducted on 8 symptoms of tingling/hot, sticky, itchy, blurred vision, foreign body sensation, dryness, glare, and pain. Assess the severity of symptoms (0-3 points) and duration of symptoms (immediate, continuous)
Measured: Administered 12 weeks after
Secondary outcomes (6)
Corneal staining test
The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system
Measured: Administered 4 weeks after
Conjunctival staining test
After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system
Measured: Administered 4 weeks after
Ocular surface disease index (OSDI)
The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.
Measured: Administered 4 weeks after
IOP(Intraocular pressure)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 10:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.
Measured: Administered 4, 12 weeks after
Tear break up time (TBUT)
After blinking blue fluorescein staining of the cobalt blue light source using a yellow filter, it was observed from the blinking point that there was a black spot, a streak pattern or a fluorine defect in the fluorescein-tear layer Was measured in seconds. The measurement results were repeated three times and average values were used.
Measured: Administered 4, 12 weeks after
Slit Lamp Biomicroscopy Findings - Limbal Redness
Slit lamp Biomicroscopy findings will be assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Measured: Administered 4, 12 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start20 Mar 2019
- Primary completion29 Jan 2021 (estimated)
- Study completion29 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Responsible party
- Principal investigator, Seungsoo Rho, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647461
- Sponsor's protocol ID
- BAT
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
- ClinicalTrials.gov ID
- NCT04647461
- Acronym / sponsor ID
- BAT
- Conditions
- Glaucoma, Ocular Hypertensive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 29 Jan 2021 (estimated)
- Study completion
- 29 Jan 2021 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
Detailed description
Following 12 weeks of administration of BRIDIN-T Eye drops 0.15%(non preservative) or ALPHAGAN-P Eye drops 0.15%(preservatives) for patients with glaucoma or Ocular Hypertensive Patients. The use of BRIDIN-T Eye drops(non preservative) is less harmful to external ophthalmicus diseases and increase of medication compliance for ophthalmic drugs than the ALPHAGAN-P Eye drops 0.15%(preservatives)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRIDIN-T Eye drops 0.15%(Non preservative) | Experimental | Drug: Brimonidine Tartrate 1.5mgBrimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes |
| ALPHAGAN-P Eye drops 0.15%(Preservatives) | Active comparator | Drug: Brimonidine Tartrate 1.5mgBrimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension
- In the case of a person receiving a glaucoma treatment drug, a person who has completed the appropriate in wash-out period for the existing glaucoma drug before the investigational product is administered.
- Intraocular pressure (IOP) >/= 15mmHg and < 40mmHg in each eye using Goldmann applanation tonometry at visit 2
- Written consent voluntarily to participate in this clinical trial
Key exclusion criteria (7 listed)
- Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
- BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
- Those who have ongoing medical history as intraocular inflamation.
- Central corneal thickness is not between 470um and 591um.
- Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brimonidine Tartrate 1.5mgAlso: BRIDIN-T Eye drops 0.15%1 drop 3 times a day for 12 weeks to target eyes | Drug | BRIDIN-T Eye drops 0.15%(Non preservative) |
| Brimonidine Tartrate 1.5mgAlso: ALPHAGAN-P Eye drops 0.15%1 drop 3 times a day for 12 weeks to target eyes | Drug | ALPHAGAN-P Eye drops 0.15%(Preservatives) |
Primary outcome
Corneal staining test
Time frame: Administered 12 weeks after
The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system
Conjunctival staining test
Time frame: Administered 12 weeks after
After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system
Ocular surface disease index (OSDI)
Time frame: Administered 12 weeks after
The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.
Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
Time frame: Administered 12 weeks after
The evaluation of satisfaction with medication is conducted with a questionnaire evaluation on the convenience of use, storage of investigational product, and the ocular tolerance. Evaluation is conducted on 8 symptoms of tingling/hot, sticky, itchy, blurred vision, foreign body sensation, dryness, glare, and pain. Assess the severity of symptoms (0-3 points) and duration of symptoms (immediate, continuous)
6 secondary outcomes
Corneal staining test
Time frame: Administered 4 weeks after
Conjunctival staining test
Time frame: Administered 4 weeks after
Ocular surface disease index (OSDI)
Time frame: Administered 4 weeks after
IOP(Intraocular pressure)
Time frame: Administered 4, 12 weeks after
Tear break up time (TBUT)
Time frame: Administered 4, 12 weeks after
Slit Lamp Biomicroscopy Findings - Limbal Redness
Time frame: Administered 4, 12 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brimonidine Tartrate 1.5mg in people with Glaucoma and Ocular Hypertensive, run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal staining test (time frame: Administered 12 weeks after). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.